Adjustable gastric banding apparatus have provided an effective and substantially less invasive alternative to gastric bypass surgery and other conventional surgical weight loss procedures. Despite the positive outcomes of invasive weight loss procedures, such as gastric bypass surgery, it has been recognized that sustained weight loss can be achieved through a laparoscopically-placed gastric band, for example, the LAP-BAND® (Allergan, Inc., Irvine, Calif.) gastric band or the LAP-BAND APO (Allergan, Inc., Irvine, Calif.) gastric band. Generally, gastric bands are placed about the cardia, or upper portion, of a patient's stomach forming a stoma that restricts the food's passage into a lower portion of the stomach. When the stoma is of an appropriate size that is restricted by a gastric band, food held in the upper portion of the stomach may provide a feeling of satiety or fullness that discourages overeating. Unlike gastric bypass procedures, gastric band apparatus are reversible and require no permanent modification to the gastrointestinal tract.
One example of a gastric banding system 105 is illustrated in FIG. 1A. As shown, a body of a patient 100 having a stomach 120 is illustrated. The gastric banding system 105 may be positioned within the patient, forming a constriction about an upper portion of the stomach 120 via a gastric band 110, and more particularly, via an inflatable portion 115 of the gastric band 110. The gastric band 110 may be connected to an access port 130 by means of a connection tube 125. A hypodermic needle 140 may penetrate the skin of the patient 100 and puncture a septum 135 of the access port 130 to add fluid to or remove fluid from the gastric band 110.
Another example of a gastric banding system is disclosed in Roslin, et al., U.S. Patent Pub. No. 2006/0235448, the entire disclosure of which is incorporated herein by this specific reference.
Over time, a stoma created by a gastric band may need adjustment in order to maintain an appropriate size, which is neither too restrictive nor too passive. Accordingly, prior art gastric band systems provide a subcutaneous fluid access port (“access port”) connected to an expandable or inflatable portion of the gastric band. By adding fluid to or removing fluid from the inflatable portion by means of a hypodermic needle inserted into the access port, the effective size of the gastric band can be adjusted to provide a tighter or looser constriction.
Typically, the different components of the gastric banding system, e.g., the access port and the inflatable portion of the gastric band, are coupled or connected to each other via tubing or other fluid conduits. In some instances, it may be practical or desirable to join two pieces of flexible tubing instead of using one long piece of tubing. As shown in FIG. 1B, the access port 130 coupled to a first tube 145 may need to be connected to a second tube 155 in order to establish a fluid path between the access port 130 and the inflatable portion 115 of the gastric band 110.
However, as the gastric banding system 105 is implanted inside a human body, leak prevention is important to reduce or eliminate the need to perform additional surgeries to fix the leaks. Currently, a tube connector 160 having barbed portions 170 and 175 for sealing purposes is being used to connect the two tubes 145 and 155, as shown in FIG. 1B. More particularly, the barbed portions 170 and 175 are utilized to provide a pressure seal and prevent leakage at the location 180 where the two tubes 145 and 155 are joined.
FIG. 1C illustrates a close up view of the tube connector 160 deployed within an inner diameter of the tubes 145 and 155. The barbed portions 170 and 175 of the tube connector 160 may prevent and/or reduce leakage by pressing against the inner diameter of the tubes 145 and 155. As such, necessarily, the barbed portions 170 and 175 have an exterior diameter that is larger than the inner diameter of the tubes 145 and 155.
FIG. 1D illustrates a cross sectional view of FIG. 1C, and more clearly shows the barbed portions 170 and 175 are larger than the inner diameters of the tubes 145 and 155, thereby causing a bulge at locations 165 and 166. Further shown is how the tube connector 160 defines a conduit 180 for coupling conduit 185 to conduit 190. Conduits 180, 185 and 190 may be utilized to carry fluid and/or other substances (e.g., air, gel, etc.) to or removing fluid and/or other substances from the inflatable portion to control the effective size of the gastric band 110.
However, the drawback to having the barb portion larger than the inner diameter of the tube is that it makes it very difficult for the barb portion to be pressed into the tube. FIG. 1E illustrates the barb portion of the tube connector just prior to insertion into the tube.
Furthermore, as with any implantation into the human body, sterility is of the utmost importance and physicians using gloves or other sterility-promoting products may have an even more difficult time when attempting to insert the barbed portion into the tube. FIG. 1F illustrates a cross sectional view of FIG. 1E. Indeed, it may take the physician much time and effort to perform said insertion of the tube connector 160 into the flexible tube 155 considering that the physician has to align the tube connector with the mating end of tube 155, while applying a significant force to cause the initial tube deformation and start the inserting process. In some situations where the tubes may be wet or slippery or very flexible, the inserting process to manipulate the tube connector into the flexible tube may be extremely frustrating.
What is needed is a system that provides the sealing capabilities of the barbed portion while providing improved ease of connecting the tubes.